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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078601

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NDA 078601 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Amneal, Caplin, Eugia Pharma, Gland, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Neocubes Pharma, Rising, and Somerset Theraps Llc, and is included in sixteen NDAs. It is available from eighteen suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for 078601

Tradename:	ROPIVACAINE HYDROCHLORIDE
Applicant:	Navinta Llc
Ingredient:	ropivacaine hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	150MG/30ML (5MG/ML)
Approval Date:	Jul 17, 2014	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	200MG/20ML (10MG/ML)
Approval Date:	Jul 17, 2014	TE:	AP	RLD:	No

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